1. Field of the Invention
The present invention relates to preparation of a biological sample for testing.
2. Description of Related Art
Biological contamination of in-process materials and finished goods occurs. Current quality control and quality assurance practices employ traditional microbiology techniques that are labor intensive and often require a 3-14 day incubation time before contamination can be detected. Contamination can occur as individual growing cells, as in the case of bacteria, or as clusters or clumps of cellular growth in the form of a network of hyphae, in the case of mold. Before the latter sample can be tested for presence or absence of contamination, the clumps of growth must be broken up into individual cells or small fragments.
Several methods of breaking up a sample have been tried with various successes. Specifically, heretofore, small homogenizers, shakers with metal balls and other mechanical means of cutting or breaking up the sample into pieces have been implemented. Even though the sample was broken up into small fragments, the results were, in most cases, unacceptable because either the fragments were not uniform, the time required to fragment the sample was too long, or debris generated by the grinding device introduced background material that masked the detection of the real sample.
It would, therefore, be desirable to provide a device and method of breaking up biological samples for the detection of biological contamination that produce results superior to all previous devices and methods, whereupon: each sample is more uniform; the generation of debris is avoided; sample preparation time is reduced; and the noise associated with sample preparation is reduced.